ICMR Calls For Proposal In Therapeutics for Inherited Rare Diseases, Apply now

The Indian Council of Medical Research (ICMR) has called for proposals on Therapeutics for Inherited Rare Diseases.

Per the notice, the last date to submit the project is 25th January 2023. Research Groups working or having expertise in the discovery and development of drugs/therapies can apply for proposals.

The project proposal should be submitted for financial support through online mode only by Scientists/ professionals who have permanent employment in Medical Institutes/ Research Institutes/ Universities/ Colleges/ recognized Research & Development laboratories/ Government and semi-government organizations and NGOs (documentary evidence of their recognition, including DSIR certificate should be enclosed with the proposal). They should have relevant experience in the field, as evident from publications of the past three years. The proposal must have at least one Co-PI from the host institute.

Collaborations are encouraged. ICMR may convert an outstanding project requiring more than 1.5 Crore/study funding to a Taskforce wherein the proposed PI will be the PI (single-centric study) or one of the PIs (multicentre study).

The process to apply –

Before submitting the proposal, ICMR has suggested reading the user manual and ICMR Extramural Research Program guidelines; and preparing all relevant information, documents and research plan (https://epms.icmr.org.in/adhoc). The applicant must open the ICMR Electronics Project Management System (e-PMS) portal http://epms.icmr.org.in. The user manual of e-PMS (under Guidelines  e-PMS manual) is available at the portal.

Project proposal submission is three steps process in e-PMS –

1. PI registration/ Login (https://epms.icmr.org.in/userLogin)

2. Verify email ID and complete/ update PI profile

3. Proposal submission

The applicants must click on "Log in" and select "Register" for new registration OR, if already registered, provide details to log in and enter into the e-PMS portal. They must verify their registered email and complete the PI profile.

Click on Submit; after completing the mandatory section of the PI profile, click on "Proposal submission.   Fill out the form step by step. Select the program from the drop-down box as "Adhoc" new proposal (Please select Broad Area: BMS, Advertise/Call: Call for Proposals on Therapeutics for Inherited Rare Diseases).

There is no separate budget head for consumables. The expense for consumables can be submitted under the contingency budget head only, along with item-wise proper justification. It is advised to read the budget provision available at Guideline for Extramural Research Program of ICMR carefully. The overhead charge will be as per ICMR order F. No. Sr.ACO/Misc.4(86226) dated 22/09/2020.

The goal of the proposal -

This proposal aims to support research and development research proposals towards developing intervention strategies on the various aspects of inherited rare diseases. The aspects included are the discovery of newer therapeutic agents and approaches and the development of repurposed drugs, biologics, genetic error corrective measures, and management to improve patient's quality of life with rare diseases such as orthopaedic/ surgical approaches, innovative management protocols etc.

Brief background -

Inherited rare diseases are infrequently occurring disorders and have been defined by countries in terms of prevalence in their population. WHO defines rare diseases as the often debilitating lifelong disorder with a prevalence of 1 or less per 1000 population. Only 5% of inherited rare disorders have treatment, among which most of the treatments are highly priced and often not available worldwide. Availability and access to medicines are important to reduce morbidity and mortality associated with rare diseases. Therefore, there is a need for research and development in intervention, technology transfer and indigenously manufactured therapeutics for rare diseases, which collaborative efforts could achieve.

Inherited rare diseases under the following groups will only be considered –

1. Storage disorders

2. Small Molecule Inborn Errors of Metabolism

3. Primary Immunodeficiency Disorders (PID)

4. Neuromuscular Disorders (NMD)

5. Hematological disorders (excluding Sickle cell diseases and Thalassemia)

6. Skeletal dysplasia

Further, ICMR has notified that approaches may include the development of resources such as cellular and animal models, vectors for genetic error corrective measures, and mechanistic aspects required for drug development as a part of the project.

These projects are time-bound with a goal-oriented approach, clearly defined targets, and specific time frames. The proposed research and development should be a potential therapeutic molecule (novel/repurposed drug) or strategies to improve patients' quality of life with rare diseases. Proposals in a multidisciplinary collaborative mode will be encouraged.

The proposal should be focused on the following –

1. Descriptive studies

2. Other systems of medicines

3. Rare cancers

4. Early stage of development, i.e., in-silico and in-vitro only

5. Biomarker

6. Registry/ Patient Database

The following points have to be kept in mind while submitting the proposal –

1. The proposal should cover achievable targets, specific time frames, justifiable budget requirements and engagement with prospective technology transfer partners or technology transfer facilitating bodies/Technology Business Incubators. Investigators should mention if they will likely have intellectual property from their study.

2. Proposal should be focused on outcomes that can be translatable.

3. The host institutions should be well-equipped and have the essential equipment and infrastructure for the proposed development. Only minor equipment may be supported based on the requirements of the proposed objectives.

4. Incomplete applications will be rejected.

5. The projects should be time-bound normally for the duration of 2-3 years.

The following criteria will be followed for evaluation –

1. Significance of the proposal

2. Innovation/ novelty

3. Project description

4. Research team's profile

5. Infrastructure

The implementation of the projects is monitored annually through a review of progress reports based on the achieved targets within the proposed timeline by an expert Committee.

Format of research plan –

The title of the proposed research project (up to 25 words) should be specific, concise, yet sufficiently descriptive and informative. The title may include study design such as a randomized controlled trial, a case-control study etc.

Summary (up to 250 words): A structured summary should contain the following subheadings: Rationale/ gaps in existing knowledge, Novelty, Objectives, Methods, and Expected outcome.

The applicants need to click on any one of the rare disease group areas of research –

1. Storage disorders

2. Small Molecule Inborn Errors of Metabolism

3. Primary Immunodeficiency Disorders (PID)

4. Neuromuscular Disorders (NMD)

5. Matological disorders (excluding Sickle cell diseases and Thalassemia)

6. Skeletal dysplasia

Six keywords separated by commas which best describe the project may be provided.

Only standard abbreviations should be used in the text. A list of abbreviations with a maximum of ten may be given.

Current status (up to 500 words): State the available information to present the problem adequately.

The study's rationale (up to 250 words): Mention how the research question addresses the critical barrier(s) in scientific knowledge, technical capability, and/or programmatic/clinical/lab practice and its relevance to local, national and international context with relevant bibliography.

Hypothesis/ Research question (up to 100 words): Please provide details.

Preliminary work done by the PI (up to 250 words): Proof of concept (if any).

Study Objectives (up to 25 words/ objective): Define the objectives clearly and in measurable terms; mention them as primary and secondary objectives if necessary. Do not include more than 3-4 objectives.

Methodology: Include an objective-wise work plan under the following sub-headings -

1. Rationale (up to 100 words)

2. Experimental design (study design, sample size, etc.) (up to 500 words)

3. Expected outcomes (up to 100 words)

4. Statistical methods (up to 50 words)

5. Pitfalls and alternate strategies (up to 100 words)

The limitations of this study are up to 100 words.

Expected outcome/ Deliverables aligned with the research question (up to 100 words).

Future plan based on expected outcomes (up to 100 words).

Will the study generate new intellectual property, or will it conflict with the existing one? The applicants need to provide the details.

Timelines with achievable targets: GANTT/ PERT chart to be included.

Execution strategy (up to 500 words): Explain how the study will be conducted, e.g., Study site(s), where the requisite number of patients be recruited, data management, available technical expertise, etc.

Institutional Support/ Facilities: Mention the efforts made to achieve inter-departmental or interinstitutional collaboration needed for study implementation, details of coordination between clinical, laboratory and data management procedures, mention -

1. Laboratory facilities (in-vitro/ in-silico)

2. Institutional resources such as instruments/ equipment and other physical resources available for use in the project proposed

3. Animal house etc.

The budget should not exceed 1.5 Crores/ study and as per ICMR guidelines available on the website. Justifications for all sub-headings under budget (as per ICMR format) will be provided in detail.

PI should suggest 2-3 reviewers well versed in the area. The suggested reviewer should not have any conflict of interest. The format is enclosed in the notice below.

PI should include a statement for conflict of declaration (if any).

Additional supplementary information, including figures, tables, flow diagrams, etc., can be shared as PDF (20-30 KB).

To view the notice, click on the link below -

https://medicaldialogues.in/pdf_upload/icmrcallforproposalrarediseases-196048.pdf